Ocean Potion Instant Dry 50 Mist Kids Sunscreen

Dosage form: spray
Ingredients: HOMOSALATE 15mL in 100mL, OCTISALATE 5mL in 100mL, OCTOCRYLENE 7mL in 100mL, AVOBENZONE 3mL in 100mL
Labeler: Sun & Skin Care Research, LLC
NDC Code: 62802-682

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients
Homosalate: 15%
Octisalate: 5%
Octocrylene: 7%
Avobenzone: 3%


Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.  Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep away from face to avoid breathing in.  Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  Flammable  Do not use near heat, flame or while smoking.  Avoid long term storage above 104°F (40°C).  Avoid spraying in eyes.  Contents under pressure.  Do not puncture or incinerate.  Do not store in temperatures above 120°F.

Directions
  • spray evenly and liberally on all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product
  • hold can 4-6 inches away from the skin to apply
  • do not spray directly on face.  Spray on hands then apply to face
  • do not apply in windy conditions.  Use in a well-ventilated area
  • reapply after 80 minutes of swimming or sweating and immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants hats and sunglasses.
  • children under 6 months: Ask a doctor

Other Information
  • For use on skin only
  • Avoid contact with fabric
  • Protect this product from excessive heat and direct sun




OCEAN POTION INSTANT DRY 50 MIST KIDS SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-682
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE15 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE7 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CHOLECALCIFEROL 
DIMETHYL CAPRAMIDE 
GLYCERIN 
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) 
Packaging
#Item CodePackage Description
1NDC:62802-682-06177 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2012
Labeler - Sun & Skin Care Research, LLC (849772207)
Establishment
NameAddressID/FEIOperations
Sun & Skin Care Research, LLC849772207manufacture

Revised: 05/2012
 
Sun & Skin Care Research, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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